BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SX OXYGENATOR Q/ HR X COATING

    MDR report key: 4344535 · Received December 10, 2014

    Report

    Report Number
    1124841-2014-00193
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Report Date
    November 21, 2014
    Product Code
    DTZ
    PMA / PMN Number
    K130359
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. (B)(4). CONCLUSION: CONCLUSION NOT YET AVAILABLE - EVAL IN PROGRESS. PRODUCT IDENTIFIER: (B)(4).

    Description of Event or Problem · 1

    DURING A CUSTOMER VISIT, A USER REPORTED ISSUES EXPERIENCED WITH ATTACHING HANSEN FITTINGS TO THE SX18 COUPLER PORTS. THIS ISSUE HAD ONLY BEEN EXPERIENCED WITH THE NEW HANSEN FITTINGS. THE OCCURRENCE DATE AND TIME IS UNK, AS WELL AS ANY IMPACT TO THE PT OR INFLUENCE ON THE OUTCOME OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797154 SX OXYGENATOR Q/ HR X COATING BLOOD GAS OXYGENATOR DTZ 3CXSX18RX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK